http://chineseinput.net/에서 pinyin(병음)방식으로 중국어를 변환할 수 있습니다.
변환된 중국어를 복사하여 사용하시면 됩니다.
그란닥신 정(토피소팜 50mg)에 대한 토핌 정의 생물학적 동등성
조혜영,정현철,허수희,임동구,문재동,이용복 한국약제학회 2001 Journal of Pharmaceutical Investigation Vol.31 No.2
Tofisopam is a new type of tranquilizer valuable for the relief of anxiety and tension in a wide range of emotional disorders. Tofisopam has the therapeutic characteristics of a minor tranquilzer and a mild stimulatory effect. The purpose of the present study was to evaluate the bioequivalence of two tofisopam tablets, Grandaxin^TM (Hwan In Pharmaceutical Co., Ltd.) and Tofim^TM (Kyung Dong Pharmaceutical Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Eighteen normal male volunteers, 23.11±2.83 years in age and 65.43±7.64 kg in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After one tablet containing 50 mg of tofisopam was orally administered, blood was taken at predetermined time intervals and the concentrations of tofisopam in serum were determined using HPLC method with UV detector. The pharmacokinetic parameters such as AUC_t C_max and T_max were calculated and ANOVA test was utilized for the statistical analysis of the parameters. The results showed that the differences in AUC_t C_max and T_max between two tablets based on the Grandaxin^TM were -5.59%, 2.22% and -13.18%, respectively. Minimum detectable differences (Δ) at α=0.10 and 1-β=0.8 were less than 20% (e.g., 14.95% and 19.34% for AUC_t and C_max respectively). The powers (1-β) at α=0.10, Δ=0.2 for AUC_t and C_max were 95.21% and 81.93%, respectively. The 90% confidence intervals were within ±20% (e.g., -15.64∼4.45 and -10.77∼15.21 for AUC_t and C_max respectively). Two parameters met the criteria of KFDA for bioequivalence, indicating that Tofim^TM tablet is bioequivalent to Grandaxin^TM tablet.
니세틸 정(아세틸 - 엘 - 카르니틴 500mg)에 대한 뉴로세틸 정의 생물학적 동등성
조혜영,오인준,이용복,임동구,문재동,심영순,김은아,정현철 한국약제학회 2001 Journal of Pharmaceutical Investigation Vol.31 No.1
Acetyl-L-carnitine (ALC), an endogenous component of the L-carnitine family, is naturally occurring molecule synthesized from L-carnitine (LC) by carnitine acetyl transferase. ALC has been shown to improve the cognitive performance of patients suffering from dementia of the Alzheimer's type and proposed for treating Alzheimer's disease in pharmacological doses. The purpose of the present study was to evaluate the bioequivalence of two ALC tablets, Nicetile^(TM) (Dong-A pharmaceutical Co., Ltd.) and Neurocetil^(TM) (Kyung-Dong Pharmaceutical Co., Ltd.), according to the guidelines of Korea Food and Drug Administration. Twenty six normal male volunteers, 22.80±2.76 year in age and 63.07±7.98 ㎏ in body weight, were divided into two groups and a randomized 2 × 2 cross-over study was employed. After one tablet containing 500 ㎎ of ALC was orally administered, blood was taken at predetermined time intervals and the concentrations of ALC in serum were determined using HPLC with fluorescence detector. Because of the presence of endogenous ALC, the calibration was performed using dialyzed serum. Pharmacokinetic parameters such as AUC_t, C_(max) and T_(max) were calculated and ANOVA was utilized for the statistical analysis of the parameters. The results showed that the differences in AUC_t, C_(max) and T_(max) between two tablets were 2.72%, -0.65% and -8.42%, respectively, when calculated against the Nicetile^(TM) tablet. The powers (1-β) for AUC_t and C_(max) were 94.87% and 87.17%, respectively. Minimum detectable differences (△) at α=0.05 and 1-β=0.8 were less than 20% (e.g., 15.58% and 19.16% AUC_t and C_(max), respectively). The 90% confidence intervals were within ±20% (e.g., -11.84∼6.41 and -10.57∼11.88 for AUC_t and C_(max), respectively). Two parameters met the criteria of KFDA for bioequivalence, indicating that Neurocetil^(TM) tablet is bioequivalent to Nicetile^(TM) tablet.
니세틸 정(아세틸-엘-카르니틴 500 mg)에 대한 뉴로세틸 정의 생물학적 동등성
조혜영,김은아,정현철,심영순,임동구,오인준,문재동,이용복 전남대학교 약품개발연구소 2001 약품개발연구지 Vol.10 No.-
Acetyl-L-carnitine (ALC), an endogenous component of the L-carnitine family, is naturally occurring molecule synthesized from L-carnitine (LC) by carnitine acetyl transferase. ALC has been shown to improve the cognitive performance of patients suffering from dementia of the Alzheimer's type and proposed for treating Alzheimer's disease in pharmacological doses. The purpose of the present study was to evaluate the bioequivalence of two ALC tablets, Nicetiler^TM (Dong-A pharmaceutical Co., Ltd.) and Neurocetil^TM (Kyung-Dong Pharmaceutical Co., Ltd.), according to the guidelines of Korea Food and Drug Administration. Twenty six normal male volunteers, 22.80±2.76 year in age and 63.07 7.98㎏ in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After one tablet containing 500㎎ of ALC was orally administered, blood was taken at predetermined time intervals and the concentrations of ALC in serum were determined using HPLC with fluorescence detector. Because of the presence of endogenous ALC, the calibration was performed using dialyzed serum. Pharmacokinetic parameters such as AUC_t, C_max and T_max were calculated and ANOVA was utilized for the statistical analysis of the parameters. The results showed that the differences in AUC_t, C_max and T_max between two tablets were 2.72%, -0.65% and -8.42%, respectively, when calculated against the Nicetile^TM tablet. The powers (1-β) for AUC_t and C_max were 94.87% and 87.17%, respectively. Minimum detectable differences (Δ) at α=0.05 and 1-β=0.8 were less than 20% (e.g., 15.58% and 19.16% AUC_t and C_max, respectively). The 90% confidence intervals were within ±20% (e.g., -11.84∼6.41 and -10.57∼11.88 for AUC_t and C_max, respectively). Two parameters met the criteria of KFDA for bioequivalence, indicating that Neurocetil^TM tablet is bioequivalent to Nicetile^TM tablet.
그란닥신 정(토피소팜 50 mg)에 대한 토핌 정의 생물학적 동등성
조혜영,정현철,허수희,임동구,문재동,이용복 전남대학교 약품개발연구소 2001 약품개발연구지 Vol.10 No.-
Tofisopam is a new type of tranquilizer valuable for the relief of anxiety and tension in a wide range of emotional disorders. Tofisopam has the therapeutic characteristics of a minor tranquilzer and a mild stimulatory effect. The purpose of the present study was to evaluate the bioequivalence of two tofisopam tablets, Grandaxin^TM (Hwan In Pharmaceutical Co., Ltd.) and Tofim^TM (Kyung Dong Pharmaceutical Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Eighteen normal male volunteers, 23.11±2.83 years in age and 65.43±7.64㎏ in body weight, were divided into two groups and a randomized 2 x 2 cross-over study was employed. After one tablet containing 50㎎ of tofisopam was orally administered, blood was taken at predetermined time intervals and the concentrations of tofisopam in serum were determined using HPLC method with UV detector. The pharmacokinetic parameters such as AUC_t, C_max and T_max were calculated and ANOVA test was utilized for the statistical analysis of the parameters. The results showed that the differences in AUC_t, C_max and T_max between two tablets based on the Grandaxin^TM were -5.59%, 2.22% and -13.18%, respectively. Minimum detectable differences (Δ) at α=0.10 and 1-β=0.8 were less than 20% (e.g., 14.95% and 19.34% for AUC_t and C_max, respectively). The powers (1-β) at α=0.10, Δ=0.2 for AUC_t and C_max were 95.21% and 81.93%, respectively. The 90% confidence intervals were within ±20% (e.g., -15.64∼4.45 and -10.77∼-15.21 for AUC_t, and C_max, respectively). Two parameters met the criteria of KFDA for bioequivalence, indicating that Tofim^TM tablet is bioequivalent to Grandaxin^TM tablet.
유한세프라딘 캅셀(세프라딘 500mg)에 대한 브로드세프 캅셀의 생물학적 동등성
조혜영,이석,강현아,오인준,임동구,문재동,이용복 한국약제학회 2002 Journal of Pharmaceutical Investigation Vol.32 No.3
Cephradine is a first generation cephalosporin and has broad spectrum antibacterial activity against gram-positive and gram-negative microorganisms, through inhibition of bacterial cell wall synthesis. Cephradine is useful for treatment of infections of the urinary and respiratory tract, skin and soft tissues. The purpose of the present study was to evaluate the bioequivalence of two cephradine capsules, Cefradine Yuhan(YuHan Corporation) and Broadcef (Ilsung Pharmaceuticals Co. Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). The cephradine release from the two cephradine capsules in vitro was tested using KP Ⅶ Apparatus Ⅱ method with various different kinds of dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty normal male volunteers, 23.10±2.90 years in age and 67.69±8.04 ㎏ in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After one capsule containing 500㎎ as cephradine was orally administered, blood was taken at predetermined time intervals and the concentrations of cephradine in serum were determined using HPLC method with UV detector. The dissolution profiles of two cephradine capsules were very similar at all dissolution media. Besides, the pharmacokinetic parameters such as AUC_t, C_max and T_max were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed AUC_t and C_max and untransformed T_max. The results showed that the differences in AUC_t C_max and T_max between two capsules based on the Cefradine Yuhan were -2.87%, -0.96% and -4.85%, respectively. There were no sequence effects between two capsules in these parameter. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log(0.8) to log(1.25) (e.g.,log(0.93)∼log(1.02) and log(0.88)∼log(1.13) for AUC_t and C)max, respectively). The 90% confidence interval using untransformed data was within ±20% (e.g., -17.54∼7.78 for T_max). All parameters met the criteria of KFDA guideline for bioequivalence, indicating that Broadcef capsule is bioequivalent to Cefradine Yuhan capsule.
무코스타정(레바미피드 100mg)에 대한 레바미드 정의 생물학적 동등성
조혜영,정현철,오인준,문재동,이용복 한국약제학회 2001 Journal of Pharmaceutical Investigation Vol.31 No.4
Rebamipide is a novel anti-gastric ulcer agent that has been reported to increase the synthesis of mucus, to increase the mucosal concentration of prostaglandin, and to promote rapid ulcer healing. The purpose of the present study was to evaluate the bioequivalence of two rebamipide tablets, Mucosta^TM (Otsuka Korea Pharmaceutical Co., Ltd.) and Rebamide^TM (Kyung Dong Pharmaceutical Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). The rebamipide release from the two rebamipide tablets in vitro was tested using KP VII Apparatus II method at pH 6.8 dissolution media. Twenty normal male volunteers, 24.20±2.26 years in age and 66.19±9.41 kg in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After one tablet containing 100 mg of rebamipide was orally administered, blood was taken at predetermined time intervals and the concentrations of rebamipide in serum were determined using HPLC method with fluorescence detector. The dissolution profiles of two rebamipide tablets were very similar at pH 6.8 dissolution media. Besides, the pharmacokinetic parameters such as AUC_t C_max and T_max were calculated and ANOVA test was utilized for the statistical analysis of the parameters. The results showed that the differences in AUC_t C_max and T_max between two tablets based on the Mucosta^TM were -2.57%, 5.77% and -1.47%, respectively. Minimum detectable differences (Δ) at α=0.05 and 1-β=0.8 were less than 20% (e.g., 12.62% and 17.63% for AUC_t and C_max respectively). The powers (1-β) at α=0.05, Δ=0.2 for AUC_t and C_max were above 99.00% and 88.56%, respectively. The 90% confidence intervals were within 20% (e.g., -9.96∼4.82 and -4.54∼16.09 for AUC_t and C_max respectively). Two parameters met the criteria of KFDA for bioequivalence, indicating that Rebamide^TM tablet is bioequivalent to Mucosta^TM tablet.
알기론 정(브롬화 시메트로피움 50 mg)에 대한 알피트 정의 생물학적 동등성
조혜영,문재동,이용복 전남대학교 약품개발연구소 2002 약품개발연구지 Vol.11 No.-
Cimetropium bromide, a quaternary ammonium compound which is chemically related to scopolamine, exhibits its antispasmodic activity by competing with acetylcholine for the muscarinic receptors of the smooth muscle of gastrointestinal tract. The drug has been used for the treatment of various disorders involving spasms of the musculature of the gastrointestinal, biliary and genitourinary tracts. The purpose of the present study was to evaluate the bioequivalence of two cimetropium bromide tablets, Algiron™ (Boehringer Ingelheim Korea Ltd.) and Alpit™ (Hana Phamaceutical Co., Ltd.), according to the prior and revised guidelines of Korea Food and Drug Administration (KDFA). The cimetropium bromide release from two cimetropium bromide tablets in vitro was tested using KP Ⅶ Apparatus Ⅱ method with various different kinds of dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty normal male volunteers, 25.25 ± 2.10 years in age and 65.76 ± 6.39 ㎏ in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After three tablets containing 50 ㎎ of cimetropium bromide per tablet were orally administered, blood was taken at predetermined time and the concentrations of cimetropium bromide in serum were determined using HPLC method with UV detector. The dissolution profiles of two cimetropium bromide tablets were very similar at all dissolution media. Besides, the pharmacokinetic parameters such as AUC_t, C_max and T_max were calculated and ANOVA test was utilized for the statistical analysis of the parameters using non-transformed and logarithmically transformed AUC_t and C_max. The results showed that the differences in AUC_t, C_max and T_max between two tablets based on the Algiron™ were 2.19%, -5.97% and 3.49%, respectively. Minimum differences (Δ) at α=0.05 and 1-β=0.8 were less than 20% (e.g., 13.71%, 19.05% and 15.11% for AUC_t, C_max and T_max, respectively). The powers (1-β) at α=0.05, Δ=0.2 for AUC_t, C_max and T_max were 97.79%, 83.22% and 95.60%, respectively. The 90% confidence intervals were within ±20% (e.g., -5.84∼10.21, -17.11∼5.18 and -5.35∼12.33 for AUC_t, C_max and T_max, respectively). There were no sequence effect between two tablets in logarithmically tanformed AUC_t, C_max. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log(0.8) to log(1.25) (e.g., 0.94∼1.10 and 0.85∼1.05 for AUC_t, C_max, respectively). Two parameters met the criteria of prior and revised KFDA guideline for bioequivalence, indicating that Alpit™ tablet is bioequivalent to Algiron™ tablet.
굴루코파지 정(염산메트폴민 500mg)에 대한 그리코민 정의 생물학적 동등성
조혜영,문재동,이용복 한국약제학회 2002 Journal of Pharmaceutical Investigation Vol.32 No.3
Metformin is an oral antihyprrglycemic agent used in the therapy of noninsulin-dependent diabetes mellitus and does not cause hypoglycemia at the therapeutic dose. Its mechanism of action may involve and increased binding of insulin to its receptors and glucose uptake at the post-receptor level. The purpose of the present study was to evaluate the bioequivalence of two metformin tablet, Glucophage (Daewoong Pharmaceutical Co., Ltd.) and Glycomin(Ilsung Pharmaceuticals Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). The metformin release from the two metformin tablets in vitro was tested using KP Ⅶ Apparatus Ⅱ method with various dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty four normal male volunteers, 23.78±1.96 years in age and 68.77±10.41㎏ in body weight, were divided into two groups with a randomized 2×2 cross-over study. After one tablet containing 500㎎ as metformin was orally administered, blood was taken at predetermined time intervals and the concentrations of metformin in serum were determined using HPLC with UV detector. Besides, the dissolution profiles of two metformin tablets were very similar at all dissolution media. The pharmacokinetic parameters such as AUC_t C_max and T_max were calculated. The ANPVA test was performed for the statistical analysis of the logarithmically transformed AUC_t and C_max, untransformed T_max. The results showed that the differences in AIC_t, C_max and T_max between two tablets based on the Glucophage were 0.09%, 6.09% and -8.22%, respectively. There were no sequence effects between two tablets in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log(0.8) ti log(1.25) (e.g.,log(0.94)∼log(1.09) and log(1.01)∼log(1.15) for AUC_t and C_max, respectively), indicating that Glycomin tablet is bioequivalent to Glucophage tablet.
아젭틴 정(염산아젤라스틴 1 mg)에 대한 아젤라 정의 생물학적 동등성
조혜영,윤지훈,서유리,오인준,이성관,문재동,이용복 전남대학교 약품개발연구소 2001 약품개발연구지 Vol.10 No.-
Azelastine, a phthalazinone derivative, is an antiallergic agent which demonstrates histamine H_1-receptor antagonist activity and also inhibits histamine release from mast cells following antigen and non-antigen stimuli. Thus, azelastine may be useful in the management of both asthma and allergic disorders. The purpose of the present study was to evaluate the bioequivalence of two azelastine hydrochloride tablets, Azeptin^TM (Bu Kwang Pharmaceutical Co., Ltd.) and Azela^TM (Kyung Dong Pharmaceutical Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Eighteen normal male volunteers, 22.44±2.01 years in age and 61.99±6.18㎏ in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After two tablets containing 1㎎ of azelastine hydrochloride per tablet were orally administered, blood was taken at predetermined time intervals and the concentrations of azelastine in serum were determined using HPLC with fluorescence detector. Pharmacokinetic parameters such as AUC_t, C_max and T_max were calculated and ANOVA test was utilized for the statistical analysis of the parameters. The results showed that the differences in AUC_t, C_max and T_max between two tablets were -6.45%, -2.60% and -7.14%, respectively, when calculated against the Azeptin^TM tablet. The powers (1-β) for AUC_t and C_max were 96.65% and 88.47%, respectively. Minimum detectable differences (Δ) at α=0.05 and 1-β=0.8 were less than 20% (e.g., 14.40% and 17.65% for AUC_t and C_max, respectively). The 90% confidence intervals were within ±20% (e.g., -14.87∼1.97 and -12.92∼7.72 for AUC_t and C_max respectively). Two parameters met the criteria of KFDA for bioequivalence, indicating that Azela^TM tablet is bioequivalent to Azeptin^TM tablet.
니세틸 정(아세틸-엘-카르니틴 500 mg)에 대한 엘카틴 정의 생물학적 동등성
조혜영,윤지훈,오인준,문재동,이용복 전남대학교 약품개발연구소 2001 약품개발연구지 Vol.10 No.-
Acetyl-L-camitine (ALC), an endogenous component of the L-carnitine family, is a naturally existing molecule synthesized from L-carnitine (LC) by carmtine acetyl transferase. ALC has been shown to improve the cognitive performance of patients suffering from dementia of the Alzheimer's type and proposed for treating Alzheimer's disease in pharmacological doses. The purpose of the present study was to evaluate the bioequivalence of two ALC tablets, Nicetile^TM (Dong-A Pharmaceutical Co.) and L-Cartin^TM (Kuhn Il Pharmaceutical Co.), according to the guidelines of Korea Food and Drug Administration (KFDA). The ALC release from the two ALC tablets in vitro was tested using KP Ⅶ Apparatus Ⅱ method in various dissolution media (pH 1.2, 6.0 and 6.8). Twenty six normal male volunteers, 24.46±3.67 years in age and 64.45±5.54 ㎏ in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After one tablet containing 500㎎ of ALC was orally administered, blood was taken at predetermined time intervals and the concentrations of ALC in serum were determined using HPLC with fluorescence detector. Because of the presence of endogenous ALC, the calibration was performed using dialyzed serum. The dissolution profiles of the two ALC tablets were similar in all the dissolution media. The pharmacokinetic parameters such as AUC_t, C_max and T_max were calculated and ANOVA was utilized for the statistical analysis of the parameters. The results showed that the differences in AUC_t, C_max and T_max between two tablets were 0.35%, 0.93% and 2.34%, respectively, when calculated against the Nicetile^TM tablet. The powers (1-β) for AUC_t and C_max were 98.72% and 85.48%, respectively. Minimum detectable differences (Δ) at α=0.05 and 1-β=0.8 were less than 20% (e.g., 13.21% and 18.42% for AUC_t and C_max, respectively). The 90% confidence intervals were within ±20% (e.g., -7.38~8.09 and -9.86~11.72 for AUC_t and C_max, respectively). These two parameters met the criteria of KFDA for bioequivalence, indicating that L-Cartin^TM tablet is bioequivalent to Nicetile^TM tablet.